Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) Prucalopride Tablets, 1 mg and 2 mg.

The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product, Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA Inc.

Prucalopride tablets are serotonin-4 receptor agonist indicated for the treatment of Chronic Idiopathic Constipation (CIC) in adults.

Prucalopride Tablets, 1 mg and 2 mg, have an estimated market size of USD 100 million for 12 months ending March 2026, according to IQVIA.

The company has a cumulative total of 245 ANDA approvals (225 final approvals and 20 tentative approvals) from FDA.